Director Upstream Process Development
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Director Upstream Process Development

King of Prussia, PA

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Summary

The Director Upstream Process Development has responsibility for the development of the upstream processes for the Center for Breakthrough Medicines asset pipeline. This includes the oversight and management of development and technology transfer (new product introductions) of the Upstream process, cell lines, cell banking, viral stocks, etc for the Viral Vector Asset from early-stage development into Manufacturing.

The Director will develop strategies and plans for programs, including clinical and commercial phases, development and manufacturing preparation phase, this role will lead the delivery of all pre-run deliverables for USP such as Materials List, Process Transfer Documents, Manufacturing Batch Records, Process Monitoring plans working with Technical Transfer and CMC leads within Process Development. This individual will work closely with the Manufacturing Team to ensure demonstration runs and pilot runs prior to GMP operation to ensure readiness and own batch success. Oversee the process development scientists and associates within their team to drive innovative and novel development to meet CMB and client shared goals and milestones. The candidate will be responsible for the development of the team and ensuring training and development metrics are met. 

Responsibilities

• Act as a leader on the team for program goals and milestones.

• Own and execute Quality by Design (QbD) for programs.

• Leverage all of The Center for Breakthrough Medicine’s process development expertise to support programs with a focus on excellence and manufacturability.

• Responsible for the development schedule adherence of to appropriate level of documentation, budget, schedule, and safety commitments.

• Support the early stage business development needs and technical workshops for new opportunities and provide appropriate Technical and programmatic input to prospective customers, including the demonstration of capability at customer visits.

• Help build, hire and develop a team of PhD & non-PhD staff that has the capability to design, plan, and execute experiments to develop and understand processes for production of therapeutic viral vector therapy.

• Make decisions, based on the professional judgment, experience, budget, cGMP and clinical regulations, and the ethical guidelines of good business practices.

• Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit.

• Evaluate the functional strengths and developmental areas in the in the USP PD team and drive a culture of continuous improvement.

• Manage team of scientists and professionals within USP PD. Hires and develops employees within the department in support of site objectives. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.

• Work with internal stakeholders in manufacturing, supply chain, BD, & Program Management for project management etc. to facilitate successful customer management.

• Independently review the design, execution, data and reporting on the development work completed within the Process Development group. Is expected to resolve (or have resolved) all technical issues.

• Key input into the development of manufacturing platforms and novel technologies.

Experience and Qualifications:

Qualifications

• Ph.D. in biochemical engineering or biological sciences with 15-20 years experience required.

• Solid foundation in the fundamentals of biochemical engineering and cell biology.

• Entrepreneurial experience dealing with customers in product development.

• Working knowledge of cGMPs related to the production of microbial therapeutics.

• Ten to fifteen years of development and scale-up experience.

• Experience with Cell Expansion technologies, single use platforms, cell banks, cell line development and optimization, viral stock generation, and suspension and adherent bioprocessing . Protein purification, protein characterization, and downstream processing are helpful, but not essential.

• Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects.

• Strategic leadership and conceptual thinking to ensure that a cost-effective organization is put in place and developed.

• Rational persuasion particularly in the discussions with customers.

• Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects.

• Ability to interpret and manipulate data, define problems, establish facts, draw valid conclusions and make decisions.

• Ability to deal with abstract and concrete variables in situations where only limited standardization exists.

• Extremely high levels of initiative and tenacity.

• Excellent oral and written communication skills

Compensation: TBD

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